FEATURED EDITORIAL
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
- They Said What? Unexpected Insights Into CDMO Selection
- A Look At Pharmaceutical Inspection Machine Advanced Technologies
- Automating Digital Twins Implementation In Downstream Bioprocessing
- Regulatory-CMC: A Core Practice For Successful CDMO Partnerships
- Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide
- Training Specifically For Tech Transfer Skills Does Exist
- A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
GUEST COLUMNISTS
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A Look At Pharmaceutical Inspection Machine Advanced Technologies
Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.
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Automating Digital Twins Implementation In Downstream Bioprocessing
One researcher describes a case study in which they simply pressed play on a set of six pre-programmed experiments and returned hours later to a complete data set.
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Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide
Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.
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A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
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New AAV Reference Standards To Aid CQA Assessment
AAVs' complexity makes them difficult analytical testing subjects. The second part of a series describes USP's latest effort to help characterize the viral vectors.
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New Reference Standards To Support Quality of AAV Raw And Starting Materials
The United States Pharmacopeia aims to help gene therapy manufacturers address the challenges that come with complex starting materials like endonuclease and plasmids.
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These Were FDA's Top Citation Issues For Data Quality In 2024
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
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2024 Trends In FDA Observations For Sterile Drug Manufacturers
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
PHARMA OUTSOURCING WHITE PAPERS
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Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing
Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.
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Next Gen rAAV Production — A Scalable Platform To Revolutionize Gene Therapy Manufacturing
Discover how our innovative rAAV production platform can revolutionize your gene therapy pipeline with unparalleled yield, quality, and scalability.
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Immunogenicity Risk Assessment In Drug Candidate Selection
Identify and address potential anti-drug immune responses early in development to streamline your drug’s path to clinical success—start smart and finish fast.
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How To Avoid Sticking And Picking In The Tableting Industry
Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.
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Digital Transformation: A Critical Component For CDMOs
Learn how embracing the digital transformation is key for managing complexity of speed, service, quality, regulatory compliance, and capacity as well as the obstacles facing CDMOs looking to innovate.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 02.12.25 -- Superior Drug Delivery: High Drug Loads And Concentrations For Small And Large Molecules
- 02.12.25 -- Training Specifically For Tech Transfer Skills Does Exist
- 02.11.25 -- Discover Clinical Supply Partners Ready For Your Clinical Studies
- 02.11.25 -- It's Partly Personal (Medicine): In 10 Years Outsourcing At $315 Billion

REPORTING: U.S. BIOSECURE ACT
- BIOSECURE Act Starts Dismantling WuXi
- BIOSECURE Act Passes House. How Will It Impact Your Outsourcing?
- Warning To U.S.-Based CDMOs: Don't Get Complacent
- Clinical Trials In China Reboot BIOSECURE Act
- Breaking: BIOSECURE Act Out. Long Live Wuxi Apptec?
- Assassination By Implication? Interview With WuXi AppTec (Part 2)
- Exclusive Interview: WuXi AppTec Responds To BIOSECURE Act
- Nothing To See Here! Just Big Pharma Investments In China
- You Want To Rein In China? Then Actually Do It
- From Ally To Adversary: BIO's Swift Rebuke Of WuXi
- BIO Expels WuXi, Agrees With U.S. Government
- Is WuXi AppTec An Enemy Of The State?
CONTENT COLLECTIONS

A great resource to help you find and evaluate the best CDMOs in the world. Included in this CDMO Leadership Awards issue are some insightful articles on development and manufacturing outsourcing.
More Content CollectionsPRODUCTS & SERVICES
ON-DEMAND WEBINARS
- CMC And Clinical Strategies For Developing Injectable, Oral Peptide Drugs
- LBA Vs. LC-MS: Competing Technologies At A Development Crossroad
- The Next Frontier In mRNA: Modular Manufacturing For Scalable RNA-LNP Therapies
- Developing And Manufacturing Minitablets To Extend Drug Lifecycle
- Adapting To Demand: The Importance Of Flexibility In HPAPI Small-Batch Manufacturing